11 babies die after pregnant women given Viagra in Dutch study

25 July 2018

It was created to look at possible beneficial effects of increased blood flow to the placenta in mothers whose unborn babies were severely underdeveloped. At the time they were treated, the mothers did not know which treatment they were receiving, which is standard in clinical trials.

It was hoped the drug would increase the size of the placenta and encourage their development. The researchers say it appears the drug, which stimulates blood flow, may have caused damage to the babies' lungs, ultimately leading to their death. The condition is essentially a type of high blood pressure in the lungs. No evidence of harm, or benefit, was observed in these trials.

In fact, the buzz on its potential has been building over the years, with rumours that doctors have already been suggesting pregnant women take the drug.

But out of the 93 women using the drug, 19 babies died, 11 of them possibly due to a form of high blood pressure in the lungs which may be linked to the drug. Six babies were born with the lung disorder and survived.

In the roughly equal control group, just three babies had lung problems and none died.

The statement from the medical center said sildenafil is sometimes used to treat women whose babies seem to not be growing well and noted that the practice will probably be discontinued. That research has now been temporarily stopped, she said.

Viagra, which is the better known name of the generic drug sildenafil, is more commonly used for men with erectile problems.

Lim told CTVNews.ca on Tuesday that he learned of the report out of the Netherlands late last week and immediately notified the study's independent Data Safety Monitoring Board and the University of British Columbia's research ethics board.

A spokesman for Amsterdam UMC said it believed the trial had been conducted properly, but would expect an external investigation to be launched.

She has no concerns for the participants of a New Zealand and Australian trial.

But the study had been paused as a precautionary measure while he gathered more information from the Dutch researchers, he said.

Recent randomised clinical trials comparing the drug with a placebo had detected no adverse effects on healthy mothers or infants, giving the all clear for others to conduct further testing.

"There have been other studies in this area, both involving preliminary work using animals and using pregnant women, and there was no indication that the treatment was risky based on previous research", Professor Evans said.